Method and apparatus for optimizing a computer assisted surgical procedure

ABSTRACT

A method and apparatus for optimizing a computer assisted procedure is provided. A method and apparatus for performing a procedure is also provided. Data can be accessed and processed to optimize and perform a procedure. The data can be augmented or supplemented with patient specific data.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 11/683,796filed on Mar. 8, 2007, which claims the benefit of U.S. ProvisionalApplication No. 60/848,442, filed on Sep. 29, 2006. The disclosures ofthe above applications are incorporated herein by reference.

FIELD

The present disclosure relates to a method and apparatus for performinga computer assisted surgical procedure, and particularly to a method andapparatus for optimizing a computer assisted surgical procedure.

BACKGROUND

The statements in this section merely provide background informationrelated to the present disclosure and may not constitute prior art.

Various procedures can be performed on the anatomy of a patient toassist in providing various treatments to the patient. For example, anorthopedic procedure can include implanting a prosthesis or repairing ananatomical structure of a patient. Additional surgical procedures caninclude neurological procedures, cardiovascular procedures, and thelike. Some of these exemplary procedures are generally selected to beperformed in a small or minimally invasive manner. Some surgicalprocedures are performed in very surgically sensitive areas of thepatient, such as in the brain or spinal area. In various procedures,therefore, an assistive system, such as an imaging or navigation systemcan be used to assist in a procedure. For example, a navigation systemcan be used to assist in illustrating a position of a device orinstrument relative to a patient.

Although imaging systems to image portions of the anatomy and navigationsystems are generally available, they may not provide multiple levels ortypes of information to the user. For example, an imaging device maygenerally only be able to provide one or two types of image data for useby a user. Nevertheless, providing several types of data for use duringa single procedure may be desirable. For example, it may be desirable toprovide a generally accepted map of a selected portion of the anatomy,such as the brain, for review during a procedure. It may also bedesirable to illustrate a map of the anatomy relative to a patientspecific image to assist in determining or verifying a location ortarget in the anatomy.

In addition, it may be desirable to provide a system that allows forintegration of numerous types of systems. For example, it may bedesirable to provide a system that allows for integration of both anavigation system, an imaging system, a data feedback system, and thelike. Therefore, it is desirable to provide a system that allows forintegration of several systems to allow for a synergistic approach toperforming a selected surgical procedure. It is also desirable toprovide an adaptive system that allows updating of static or databasemodels to optimize various surgical procedures.

SUMMARY

Taught herein is a method and apparatus for providing an integratedadaptive system and approach to performing a surgical procedure. Thissystem may be provided to obtain or display a selected type of datarelating to a portion of the anatomy, and the system may allow for thesynergy of several types of information for a single user. For example,image data of a particular patient, atlas information, instrument orrecorder information, navigation information, archived or historicalinformation, patient specific information and other appropriate types ofinformation. All can be provided on or by a single system for use by auser during an operative procedure, after an operative procedure, orprior to an operative procedure.

In one example, various types of data can be provided to a user to plana selected procedure. The plan and various types of data can be providedto a user during the actual procedure to assist navigating and assuringthat the procedure is performed according to the plan. The data can alsoallow a user to perform a follow-up or programming of a device for aparticular procedure. The data can assist the user in ensuring that anappropriate therapy is provided to a selected area of the anatomy, suchas the brain. In addition, the various types of data can be used topost-operatively assist in refining various databases of data, such asatlases, including the anatomical and functional locations definedtherein.

Further areas of applicability will become apparent from the descriptionprovided herein. It should be understood that the description andspecific examples are intended for purposes of illustration only and arenot intended to limit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustration purposes only and arenot intended to limit the scope of the present disclosure in any way.

FIG. 1 is a schematic block diagram of an optimization system accordingto various embodiments;

FIG. 2 is an environmental view of a navigation system according tovarious embodiments;

FIG. 2A is an environmental view of a navigation system according tovarious embodiments;

FIG. 2B is an environmental view of a navigation system according tovarious embodiments;

FIG. 3 is an illustration of three-dimensional atlas data according tovarious embodiments;

FIG. 4 is an illustration of image data and atlas data according tovarious embodiments;

FIG. 5 is an illustration of image data and planning data according tovarious embodiments;

FIG. 6 is an illustration of various types of data including image data,physiological data, icon data, atlas data, according to variousembodiments;

FIG. 7 is an illustration of tracking and positioning of a devicerelative to an anatomy;

FIG. 8 is a perspective view of a work station including a displaydisplaying various types of data according to various types ofembodiments;

FIG. 9A is an illustration of an affect of a therapy according tovarious embodiments;

FIG. 9B is a display of image data including an icon representing anaffected area according to a selected therapy according to variousembodiments;

FIG. 10A is image data including an icon representing a selectedtherapy's affect on the anatomy;

FIG. 10B is an illustration of image data with an icon representing anarea of the anatomy affected by a selected therapy;

FIG. 11 is a block diagram graphical representation of an optimizationsystem; and

FIG. 12 is an illustration of physiological data according to variousembodiments.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is notintended to limit the present disclosure, application, or uses.

With reference to FIG. 1, an optimization or synergistic system 1 isillustrated. The optimization system 1 can allow the provision ofnumerous types of data to be used or provided for planning a procedure,performing a procedure, optimizing a procedure, or assisting in updatingor enhancing the data 2. The data 2 can include various types of data.Exemplary data can include atlas data 2 a, patient image data 2 b,acquired physiological data 2 c, patient specific data 2 d, and archivedor statistical functional data 2 e.

The various types of data 2 can be provided within the optimizationsystem of 1 for use in various portions of the optimization procedure 1The optimization system 1 can include a procedure planning 3, performinga procedure 4, or optimizing and programming a system 5, such as animplantable device. The various types of data 2 can be provided in anyappropriate manner, such as visually, a list, a database, a computeraccessible database, or the like.

The various types of data 2, although only exemplary and not intended tobe an exhaustive list, can include atlas data 2 a. The atlas data 2 acan be any appropriate atlas data, such as a neurological atlas data, acardiovascular atlas data, a musculature atlas data, skeletal atlasdata, or the like. The atlas data can include three-dimensional atlasdata 100 (FIG. 3) of selected portions of the anatomy. For example,atlas data can include three-dimensional atlas data of a neurologicalfeature or structure, such as the sub-thalamic nucleus, variousventricles, and the like. Atlas data can also include two-dimensionalatlas data 102 (FIG. 4) of portions of the anatomy, such as neurologicalportions. Other atlas data can also include the various boundaries ofanatomical or functional features, locations of various anatomical orfunctional features, or any appropriate atlas data. Generally, the atlasdata can be understood to be a well defined image data of a single ormultiple patients. Generally accepted locations of functional oranatomical locations in an anatomy can be provided in the atlas data.The atlas data, as discussed further herein, can then be used todetermine various functional or anatomical locations within an imagedata of a particular patient.

The data 2 provided within the optimization system 1 can also includethe patient specific image data 2 b. The patient specific image data 2 bcan be acquired in any appropriate manner, including those discussedfurther herein. The acquired image data can include magnetic resonanceimaging data, diffusion tensor image data, optical coherence tomographyimage data, x-ray image data, or any appropriate image data. The patientimage data can be acquired at any appropriate time, such aspre-operatively, intra-operatively or post-operatively. Also, asdiscussed further herein, the patient image data 2 b can be registeredto the atlas data 2 a for use by a user within the optimization system1. The atlas data 2 a can be fitted to the image data of the patient 2 bin any appropriate manner, also discussed further herein.

Also, other types of exemplary patient data that can be acquired, caninclude physiological data 2 c. The physiological data 2 c can be anyappropriate type of data, such as electrical signal data recorded with amicro-electrode recorder (MER). Micro-electrode recording is understoodby one skilled in the art and can be used to precisely pin point orlocate various portions of the anatomy. For example, the MER can be usedto determine the electrical signal relative to a single neuron or to agroup of neurons. Further, the MER can be moved through the neurologicaltissue to determine differences between selected regions of a patient.The acquired physiological data, however, can also include anyappropriate type of data, such as optical coherence tomography data 220(see FIG. 12), temperature data, hydraulic data, or the like. Theacquired physiological data can also be used with or superimposed onvarious types of patient specific data, such as the patient image data 2b. The acquired physiological data 2 c can also be used to assist in anappropriate registration, re-registration or superimposing of the atlasdata 2 a onto the patient image data 2 b.

In addition, various patient specific data in block 2 d can also beprovided. The patient specific data 2 d can also include data, such asprior procedures, physical issues with the particular patient 14, or anyappropriate patient specific data. The patient specific data 2 d canalso include a particular geometry or the patient, known locations ofportions of the anatomy of the patient, and the like. Patient specificdata 2 d can also include functional data of the patient. Also, patientspecific data can include function data acquired during a particularprocedure. Functional data can include microelectrode recording data,pressure data, gating data, etc. Functional data, according to variousembodiments, can be obtained with a microelectrode recorder, a scope, acatheter, or any other appropriate instrument.

In addition, as discussed above, the data 2 can include various archivedor multiple procedural data portions or data sets 2 e. Although variousportions of the data can be integrated into the atlas data 2 a, anadditional database of data can include the archived or statisticalfunctional data 2 e. The archived and statistical functional data 2 ecan include data obtained during the performance of the procedure inblock 4 or during the optimization and programming of the device, whichcan be implanted in the patient 14 in block 5. Archived or statisticalfunctional data 2 e can also include functional data of a group orprevious patients. Functional data can include microelectrode recordingdata, pressure data, gating data, etc. The archived functional data canbe used to augment data base data, including an atlas or otherappropriate data. Therefore, the data in block 2 can include both datarelating to the particular patient and to historical data that canassist in optimizing static data, such as atlas data, to a particularpatient.

It will be understood that the system 1, as illustrated in FIG. 11, caninclude a substantially graphical interface that allows for bothrepresentation of the static and archived data and for manipulation ofthe data. Further, the archived data can be provided in a graphicalmanner relative to the patient specific data for illustration andreference during a particular procedure.

The data 2 can be provided to any appropriate procedure planning system3. As discussed further herein, the data 2 can also be provided to anoptimization or programming system for a device 5. The data 2 can beused in the procedure planning 3 or in the optimization programmingsystem 5 to enhance or optimize a procedure on a particular patient. Forexample, the procedure planning block 3 can use the data 2 to assist inpre-selecting a target for a therapy, selecting a trajectory to reachthe target for therapy, determining an appropriate amount of therapy,determining an appropriate type of therapy, or other appropriatepre-surgical planning information.

The data 2 can be provided, generally, in a database for access by asystem or user. As discussed further herein, a workstation including aprocessor or any appropriate processor can execute instructions relatingto the data base of the data 2. The database of the data 2 can be storedon a memory system for access by the processor. Thus, the data 2 can beaccessed for use during a procedure, as discussed herein.

Also, as discussed further herein, a feedback 6 can allow the databaseof the data 2 to be augmented or updated. The database data 2 can beaugmented or updated for use in multiple procedures or only in a currentprocedure. In this way, the data 2 in the database can be used in one ormultiple procedures and accessed by multiple users. Thus, the data 2 canbe used to optimize or assist in several procedures and updated andimproved over time.

The data 2 in the database, can be accessed for use in a procedure. Thedata 2 in the database can be stored on a local memory system oraccessed via a communications network. This can allow a centralizedstorage and access of the data 2 to efficiently update and augment thedata 2 with numerous procedure data.

In planning a procedure, the patient image data 2 b can be furtherrefined with the acquired physiological data 2 c or other patientspecific information 2 d. This can assist determining the location ofthe various anatomical or functional locations. Further, the data 2 canalso include specific inputs or database inputs of the effectivetherapies on selected portions of the anatomy. For example, knowneffects of electrical stimulation, material delivery, or the like can beprovided to assist in planning a procedure, including the amounts ortype of therapy to be provided to a selected target or region.

Also, as discussed herein and illustrated in FIGS. 8-10B, various typesof data can be used to illustrate the affect on the anatomy during aprogramming in the optimization of programming in block 5. However, thisdata can also be used pre-operatively, when illustrated relative to aselected location, such as a target location, to illustrate a possibleaffect of a therapy to be provided at the selected location. Therefore,the image data, atlas data, and the other database data can be used toplan a procedure. For example, an icon representing the implanted probecan be positioned on the image data of the patient and an iconrepresenting an area affected by the therapy can be displayed relativeto the probe. Planning the procedure can be used to select an optimallocation, an optimal therapy based upon the optimal location, an optimaltrajectory to attempt to reach the application, and the like. Theinstrument that is implanted can include a plurality of instruments,such as a plurality of DBS leads. Each of the instruments can beactivated or used separately or together to provide a therapy.

The procedure planned in block 3 can also be performed in block 4 withthe assistance of the data 2. As discussed herein, a device orinstrument can be navigated relative to a patient, based upon theplanned procedure from block 3, which is based upon the data from block2. The navigation can be substantially imageless or with images toassist in ensuring that an appropriate location of the instrument ordevice is reached. Further, the data can be used to illustrate the typeof therapy being provided and the effect of the therapy being providedto the patient. Also, various imaging techniques can be used tointraoperatively verify positioning of a selected device to ensure thatthe plan from the procedure planning of block 3 has been achieved.

As understood by one skilled in the art, various types of devices may beprogrammed or optimized once they are implanted or positioned relativeto a patient. For example, a deep brain stimulator (DBS) probe can beimplanted into the brain and can be programmed over time to achieve anoptimal result. It will be understood, however, that various types ofimplantable devices can also be employed to provide any appropriate typeof therapy, such as a pacing lead, a drug delivery therapy, apharmaceutical delivery, a cell or gene delivery therapy, or anyappropriate type of therapy and delivery. Therefore, the optimizationand programming system in block 5 can use the data from block 2 toassist in determining the appropriate type of programming that should beprovided. For example, also discussed further herein, an appropriatevoltage and pulse width can be programmed for an appropriate lead tostimulate a selected portion of the anatomy. The data from block 2 canbe used to assist in determining the appropriate voltage, theappropriate pulse width, and the appropriate lead to be activated.

Also, the optimization and programming system for the device 5 can beused to assist in creating or augmenting the data in block 2, viafeedback 6. For example, when providing a selected voltage, pulse width,and the like achieves the selected result or achieves a particularresult, the data from block 2 can be augmented or changed based upon theobserved result. The optimal location or optimal initial voltage, pulsewidth, therapy delivery, or the like can be input for retrieval whenplanning a procedure 3 from the data block 2.

The procedure can be planned or performed with any appropriate system,which can include a navigation system 10 (FIG. 2). The navigation system10 can be used by any appropriate individual, such as a user to assistin both planning and performing a procedure. Nevertheless, the data 2can be used and processed by a user or an electronic processor to assistin planning or performing a procedure.

With reference to FIG. 2 the navigation system 10 that can be used forvarious procedures in relation to the optimized therapy plan and system1. The navigation system 10 can be used to track the location of adevice, such as a delivery device, relative to a patient 14 to assist inthe implementation of the plan in block 3, and discussed herein. Itshould be further noted that the navigation system 10 may be used tonavigate or track other devices including: catheters, probes, needles,leads, implants, etc. Moreover, the navigated device may be used in anyregion of the body. The navigation system 10 and the various devices maybe used in any appropriate procedure, such as one that is generallyminimally invasive, arthroscopic, percutaneous, stereotactic, or an openprocedure. Although an exemplary navigation system 10 including animaging system 12 are discussed herein, one skilled in the art willunderstand that the disclosure is merely for clarity of the presentdiscussion and any appropriate imaging system, navigation system,patient specific data, and non-patient specific data can be used. Forexample, the imaging system can include an MRI imaging system 12′ (FIG.2A) or an O-arm imaging system 12″ (FIG. 2B).

The navigation system 10 can include the optional imaging device 12 thatis used to acquire pre-, intra-, or post-operative or real-time imagedata of a patient 14. The image data acquired with the imaging device 12can be used as part of the patient specific information in block 2.Alternatively various imageless systems can be used or images from atlasmodels can be used to produce patient images, such as those disclosed inU.S. patent application Ser. No. 10/687,539, filed Oct. 16, 2003,entitled “METHOD AND APPARATUS FOR SURGICAL NAVIGATION OF A MULTIPLEPIECE CONSTRUCT FOR IMPLANTATION”, incorporated herein by reference. Theoptional imaging device 12 is, for example, a fluoroscopic X-ray imagingdevice that may be configured as a C-arm 16 having an X-ray source 18,an X-ray receiving section 20, an optional calibration and trackingtarget 22 and optional radiation sensors 24. The calibration andtracking target 22 includes calibration markers (not illustrated). Imagedata may also be acquired using other imaging devices, such as thosediscussed above and herein.

An optional imaging device controller 28 may control the imaging device12, such as the C-arm 16, which can capture the x-ray images received atthe receiving section 20 and store the images for later use. Thecontroller 28 may also be separate from the C-arm 16 and can be part ofor incorporated into a work station 31. The controller 28 can controlthe rotation of the C-arm 16. For example, the C-arm 16 can move in thedirection of arrow 30 or rotate about a longitudinal axis 14 a of thepatient 14, allowing anterior or lateral views of the patient 14 to beimaged. Each of these movements involves rotation about a mechanicalaxis 32 of the C-arm 16. The movements of the imaging device 12, such asthe C-arm 16 can be tracked with a tracking device 59.

In the example of FIG. 2, the longitudinal axis 14 a of the patient 14is substantially in line with the mechanical axis 32 of the C-arm 16.This enables the C-arm 16 to be rotated relative to the patient 14,allowing images of the patient 14 to be taken from multiple directionsor about multiple planes. An example of a fluoroscopic C-arm x-raydevice that may be used as the optional imaging device 12 is the “Series9600 Mobile Digital Imaging System,” from GE Healthcare, (formerly OECMedical Systems, Inc.) of Salt Lake City, Utah. Other exemplaryfluoroscopes include bi-plane fluoroscopic systems, ceiling fluoroscopicsystems, cath-lab fluoroscopic systems, fixed C-arm fluoroscopicsystems, isocentric C-arm fluoroscopic systems, 3D fluoroscopic systems,intraoperative O-arms, etc.

In operation, the C-arm 16 generates X-rays from the −X-ray source 18that propagate through the patient 14 and calibration and/or trackingtarget 22, into the X-ray receiving section 20. This allows directvisualization of the patient 14 and radio-opaque instruments in the coneof X-rays. It will be understood that the tracking target or device neednot include a calibration portion. The receiving section 20 generatesimage data representing the intensities of the received X-rays.Typically, the receiving section 20 includes an image intensifier thatfirst converts the X-rays to visible light and a charge coupled device(CCD) video camera that converts the visible light into digital imagedata. Receiving section 20 may also be a digital device that convertsX-rays directly to digital image data for forming images, thuspotentially avoiding distortion introduced by first converting tovisible light. With this type of digital C-arm, which is generally aflat panel device, the optional calibration and/or tracking target 22and the calibration process discussed below may be eliminated. Also, thecalibration process may be eliminated or not used at all for variousprocedures. Alternatively, the imaging device 12 may only take a singleimage with the calibration and tracking target 22 in place. Thereafter,the calibration and tracking target 22 may be removed from theline-of-sight of the imaging device 12.

Two dimensional fluoroscopic images that may be taken by the imagingdevice 12 are captured and stored in the C-arm controller 28. Multipletwo-dimensional images taken by the imaging device 12 may also becaptured and assembled to provide a larger view or image of a wholeregion of a patient, as opposed to being directed to only a portion of aregion of the patient. For example, multiple image data of a patient'sleg or cranium and brain may be appended together to provide a full viewor complete set of image data of the leg or brain that can be later usedto follow contrast agent, such as Bolus or therapy tracking.

The image data can then be forwarded from the C-arm controller 28 to anavigation computer and/or processor controller or work station 31having a display 34 to display image data 36 and a user interface 38.The work station 31 can also include or be connected to an imageprocessor, navigation processor, and memory to hold instruction anddata. The work station 31 can include an optimization processor, whichincludes the system 1, as discussed herein, or a separate optimizationprocessor system 39 can be included. The optimization processor system39 can also include a display 39 a and a user input 39 b. It will alsobe understood that the image data is not necessarily first retained inthe controller 28, but may also be directly transmitted to theworkstation 31, which can also include an image processor, navigationprocessor, memory, etc. Moreover, processing for the navigation systemand optimization can all be done with a single or multiple processors.

The work station 31 or optimization processor 39 provides facilities fordisplaying the image data 36 as an image on the display 34, saving,digitally manipulating, or printing a hard copy image of the receivedimage data. The user interface 38, which may be a keyboard, mouse, touchpen, touch screen or other suitable device, allows a physician or user67 to provide inputs to control the imaging device 12, via the C-armcontroller 28, or adjust the display settings of the display 34. Thework station 31 may also direct the C-arm controller 28 to adjust therotational axis 32 of the C-arm 16 to obtain various two-dimensionalimages along different planes in order to generate representativetwo-dimensional and three-dimensional images.

The optimization processor 39 can be provided in any appropriate format,such as a substantially portable format. The optimization processor 39can be used in any appropriate portion of the optimization process orsystem 1. For example, the optimization processor 39 can be separatefrom the navigation processor to allow for planning of the procedure,programming of the device in step 5, or any appropriate portion.

Various calibration techniques can be used to calibrate the imagingdevice 12. Intrinsic calibration, which is the process of correctingimage distortion in a received image and establishing the projectivetransformation for that image, involves placing the calibration markersin the path of the x-ray, where the calibration markers are opaque orsemi-opaque to the x-rays. A more detailed explanation of exemplarymethods for performing intrinsic calibration are described in thereferences: B. Schuele, et al., “Correction of Image IntensifierDistortion for Three-Dimensional Reconstruction,” presented at SPIEMedical Imaging, San Diego, Calif., 1995; G. Champleboux, et al.,“Accurate Calibration of Cameras and Range Imaging Sensors: the NPBSMethod,” Proceedings of the IEEE International Conference on Roboticsand Automation, Nice, France, May, 1992; and U.S. Pat. No. 6,118,845,entitled “System And Methods For The Reduction And Elimination Of ImageArtifacts In The Calibration Of X-Ray Imagers,” issued Sep. 12, 2000,the contents of which are each hereby incorporated by reference.

While the optional imaging device 12 is shown in FIG. 2, any otheralternative 2D, 3D or 4D imaging modality may also be used. For example,any 2D, 3D or 4D imaging device, such as isocentric fluoroscopy,bi-plane fluoroscopy, ultrasound, computed tomography (CT), multi-slicecomputed tomography (MSCT), magnetic resonance imaging (MRI), highfrequency ultrasound (HIFU), positron emission tomography (PET), opticalcoherence tomography (OCT) (a more detailed discussion on opticalcoherence tomography (OCT), is set forth in U.S. Pat. No. 5,740,808,issued Apr. 21, 1998, entitled “Systems And Methods For GuidingDiagnostic Or Therapeutic Devices In Interior Tissue Regions” which ishereby incorporated by reference), intra-vascular ultrasound (IVUS),intra-operative CT, single photo emission computed tomography (SPECT),planar gamma scintigraphy (PGS). Addition imaging systems includeintraoperative MRI systems 12. (FIG. 2A), such as the PoleStar® MRIsystem sold by Medtronic, Inc. Further systems include the O-Arm™imaging system 12 (FIG. 2B) sold by Breakaway Imaging, LLC. The imagesmay also be obtained and displayed in two, three or four dimensions. Inmore advanced forms, four-dimensional surface rendering regions of thebody may also be achieved by incorporating patient data or other datafrom an atlas or anatomical model map or from pre-operative image datacaptured by MRI, CT, or echocardiography modalities.

Image datasets from hybrid modalities, such as positron emissiontomography (PET) combined with CT, or single photon emission computertomography (SPECT) combined with CT, could also provide functional imagedata superimposed onto anatomical data to be used to confidently reachtarget sights within the patient 14. It should further be noted that theoptional imaging device 12, as shown in FIG. 2, provides a virtualbi-plane image using a single-head C-arm fluoroscope as the optionalimaging device 12 by simply rotating the C-arm 16 about at least twoplanes, which could be orthogonal planes to generate two-dimensionalimages that can be converted to three-dimensional volumetric images. Byacquiring images in more than one plane, an icon representing thelocation of an impacter, stylet, reamer driver, taps, drill, or otherinstrument, or probe introduced and advanced in the patient 14, may besuperimposed in more than one view on display 34 allowing simulatedbi-plane or even multi-plane views, including two and three-dimensionalviews.

4D image information can be used with the navigation system 10 as well.For example, the user 67 can use the physiologic signal 2C, which caninclude Heart Rate (EKG), Breath Rate (Breath Gating) and combine thisdata with image data 2 b acquired during the phases of the physiologicsignal to represent the anatomy at various stages of the physiologiccycle. For example, the brain pulses (and therefore moves) with eachheartbeat. Images can be acquired to create a 4D map of the brain, ontowhich the atlas data 2 a and representations of the instrument can beprojected. This 4D data set can be matched and co-registered with thephysiologic signal (EKG) to represent a compensated image within thesystem. The image data registered with the 4D information can show thebrain (or anatomy of interest) moving during the cardiac or breathcycle. This movement can be displayed on the display 34 as the imagedata 36.

Likewise, other imaging modalities can be used to gather the 4D datasetto which pre-operative 2D and 3D data can be matched. One need notnecessarily acquire multiple 2D or 3D images during the physiologiccycle of interest (breath or heart beat). Ultrasound imaging or other 4Dimaging modalities can be used to create an image data that allows for asingular static pre-operative image to be matched via image-fusiontechniques and/or matching algorithms that are non-linear to match thedistortion of anatomy based on the movements during the physiologiccycle. The combination of a the dynamic reference frame 54 and 4Dregistration techniques can help compensate for anatomic distortionsduring movements of the anatomy associated with normal physiologicprocesses.

With continuing reference to FIG. 2, the navigation system 10 canfurther include an electromagnetic navigation or tracking system 44 thatincludes a localizer, such as a coil array 46 and/or second coil array47, the coil array controller 48, a navigation probe interface 50, adevice 52 (e.g. catheter, needle, or instruments, as discussed herein)and a dynamic reference frame 54. Other tracking systems can includeoptical tracking systems 44′, 44″ exemplary optical tracking systemsinclude the StealthStation® Treon® and the StealthStation® Tria® bothsold by Medtronic Navigation, Inc. The dynamic reference frame 54 caninclude a dynamic reference frame holder 80 and a removable trackingdevice 54 a. Alternatively, the dynamic reference frame 54 can include atracking device 54 a that is formed integrally with the dynamicreference frame holder 80.

The tracking device 54 a or any appropriate tracking device as discussedherein, can include both a sensor, a transmitter, or combinationsthereof. Further, the tracking devices can be wired or wireless toprovide a signal or emitter or receive a signal from a system.Nevertheless, the tracking device can include an electromagnetic coil tosense a field produced by the localizing array 46 or 47 or reflectorsthat can reflect a signal to be received by the optical localizer 44′,44″. Nevertheless, one will understand that the tracking device canreceive a signal, transmit a signal, or combinations thereof to provideinformation to the navigation system 10 to determine a location of thetracking device 54 a, 58. The navigation system can then determine aposition of the instrument or tracking device to allow for navigationrelative to the patient and patient space.

The coil arrays 46, 47 may also be supplemented or replaced with amobile localizer. The mobile localizer may be one such as that describedin U.S. patent application Ser. No. 10/941,782, filed Sep. 15, 2004, andentitled “METHOD AND APPARATUS FOR SURGICAL NAVIGATION”, hereinincorporated by reference. As is understood the localizer array cantransmit signals that are received by the tracking device 54 a, 58. Thetracking device 58 can then transmit or receive signals based upon thetransmitted or received signals from or to the array.

Other tracking systems include acoustic, radiation, radar, infrared,etc. The optical localizer can transmit and receive, or combinationsthereof. An optical tracking device can be interconnected with theinstrument 52, or other portions such as the dynamic reference frame 54.As is generally known the optical tracking device 58 a can reflect,transmit or receive an optical signal to the optical localizer 44′ thatcan be used in the navigation system 10 to navigate or track variouselements. Therefore, one skilled in the art will understand, that thetracking devices 54 a, 58, and 59 can be any appropriate tracking deviceto work with any one or multiple tracking systems.

Further included in the navigation system 10 may be an isolator circuitor assembly. The isolator circuit or assembly may be included in atransmission line to interrupt a line carrying a signal or a voltage tothe navigation probe interface 50. Alternatively, the isolator circuitincluded in the isolator box may be included in the navigation probeinterface 50, the device 52, the dynamic reference frame 54, thetransmission lines coupling the devices, or any other appropriatelocation. The isolator assembly is operable to isolate any of theinstruments or patient coincidence instruments or portions that are incontact with the patient should an undesirable electrical surge orvoltage take place.

It should further be noted that the entire tracking system 44 or partsof the tracking system 44 may be incorporated into the imaging device12, including the work station 31, radiation sensors 24 and optimizationprocessor 39. Incorporating the tracking system 44 may provide anintegrated imaging and tracking system. This can be particularly usefulin creating a fiducial-less system. Any combination of these componentsmay also be incorporated into the imaging system 12, which again caninclude a fluoroscopic C-arm imaging device or any other appropriateimaging device.

The coil array 46 can include a plurality of coils that are eachoperable to generate distinct electromagnetic fields into the navigationregion of the patient 14, which is sometimes referred to as patientspace. Representative electromagnetic systems are set forth in U.S. Pat.No. 5,913,820, entitled “Position Location System,” issued Jun. 22, 1999and U.S. Pat. No. 5,592,939, entitled “Method and System for Navigatinga Catheter Probe,” issued Jan. 14, 1997, each of which are herebyincorporated by reference.

The coil array 46 is controlled or driven by the coil array controller48. The coil array controller 48 drives each coil in the coil array 46in a time division multiplex or a frequency division multiplex manner.In this regard, each coil may be driven separately at a distinct time orall of the coils may be driven simultaneously with each being driven bya different frequency.

Upon driving the coils in the coil array 46 with the coil arraycontroller 48, electromagnetic fields are generated within the patient14 in the area where the medical procedure is being performed, which isagain sometimes referred to as patient space. The electromagnetic fieldsgenerated in the patient space induce currents in the tracking device 54a, 58 positioned on or in the device 52. These induced signals from thetracking device 58 are delivered to the navigation probe interface 50and subsequently forwarded to the coil array controller 48. Thenavigation probe interface 50 can also include amplifiers, filters andbuffers to directly interface with the tracking device 58 in the device52. Alternatively, the tracking device 58, or any other appropriateportion, may employ a wireless communications channel, such as thatdisclosed in U.S. Pat. No. 6,474,341, entitled “Surgical CommunicationPower System,” issued Nov. 5, 2002, herein incorporated by reference, asopposed to being coupled directly to the navigation probe interface 50.

Various portions of the navigation system 10, such as the device 52, thedynamic reference frame (DRF) 54, the instrument 52, are equipped withat least one, and generally multiple, EM or other tracking devices 58,that may also be referred to as localization sensors. The EM trackingdevices 58 can include one or more coils that are operable with the EMlocalizer array 46 or 47. An alternative tracking device may include anoptical sensor, and may be used in addition to or in place of theelectromagnetic sensor 58. The optical sensor may work with the optionaloptical array 44′. One skilled in the art will understand, however, thatany appropriate tracking device can be used in the navigation system 10.An additional representative alternative localization and trackingsystem is set forth in U.S. Pat. No. 5,983,126, entitled “CatheterLocation System and Method,” issued Nov. 9, 1999, which is herebyincorporated by reference. Alternatively, the localization system may bea hybrid system that includes components from various systems.

In brief, the EM tracking device 58 on the device 52 can be in a handleor inserter that interconnects with an attachment and may assist inplacing an implant or in driving a portion. The device 52 can include agraspable or manipulable portion at a proximal end and the trackingdevice 58 may be fixed near the manipulable portion of the device 52 orat a distal working end, as discussed herein. The tracking device 58 caninclude an electromagnetic sensor to sense the electromagnetic fieldgenerated by the coil array 46 that can induce a current in theelectromagnetic device 58. Alternatively, the tracking sensor 54 a, 58can be driven (i.e., like the coil array above) and the tracking array46, 46 a can receive a signal produced by the tracking device 54 a, 58.

The dynamic reference frame 54 may be fixed to the patient 14 adjacentto the region being navigated so that any movement of the patient 14 isdetected as relative motion between the coil array 46 and the dynamicreference frame 54. The dynamic reference frame 54 can be interconnectedwith the patient in any appropriate manner, including those discussedherein. This relative motion is forwarded to the coil array controller48, which updates registration correlation and maintains accuratenavigation, further discussed herein. The dynamic reference frame 54 maybe any appropriate tracking sensor used as the dynamic reference frame54 in the navigation system 10. Therefore the dynamic reference frame 54may also be optical, acoustic, etc. If the dynamic reference frame 54 iselectromagnetic it can be configured as a pair of orthogonally orientedcoils, each having the same center or may be configured in any othernon-coaxial or co-axial coil configurations.

Briefly, the navigation system 10 operates as follows. The navigationsystem 10 creates a translation map between all points in the image datagenerated from the imaging device 12 which can include external andinternal portions, and the corresponding points in the patient's anatomyin patient space. After this map is established, whenever the trackeddevice 52 is used the work station 31 in combination with the coil arraycontroller 48 and the C-arm controller 28 uses the translation map toidentify the corresponding point on the pre-acquired image or atlasmodel, which is displayed on display 34. This identification is known asnavigation or localization. An icon representing the localized point orinstruments is shown on the display 34 within several two-dimensionalimage planes, as well as on three and four dimensional images andmodels.

To enable navigation, the navigation system 10 must be able to detectboth the position of the patient's anatomy and the position of theinstrument 52 or attachment member (e.g. tracking device 58) attached tothe instrument 52. Knowing the location of these two items allows thenavigation system 10 to compute and display the position of theinstrument 52 or any portion thereof in relation to the patient 14. Thetracking system 44 is employed to track the instrument 52 and theanatomy simultaneously.

The tracking system 44, if it is using an electromagnetic trackingassembly, essentially works by positioning the coil array 46 adjacent tothe patient space to generate a magnetic field, which can be low energy,and generally referred to as a navigation field. Because every point inthe navigation field or patient space is associated with a unique fieldstrength, the electromagnetic tracking system 44 can determine theposition of the instrument 52 by measuring the field strength at thetracking device 58 location. The dynamic reference frame 54 is fixed tothe patient 14 to identify the location of the patient in the navigationfield. The electromagnetic tracking system 44 continuously recomputesthe relative position of the dynamic reference frame 54 and theinstrument 52 during localization and relates this spatial informationto patient registration data to enable image guidance of the device 52within and/or relative to the patient 14.

Patient registration is the process of determining how to correlate theposition of the instrument 52 relative to the patient 14 to the positionon the diagnostic or pre-acquired images. To register the patient 14, aphysician or user 67 may use point registration by selecting and storingparticular points (e.g. fiducial points 60) from the pre-acquired imagesand then touching the corresponding points on the patient's anatomy withthe pointer probe 66. The navigation system 10 analyzes the relationshipbetween the two sets of points that are selected and computes a match,which correlates every point in the image data with its correspondingpoint on the patient's anatomy or the patient space. The points that areselected to perform registration are the fiducial markers or landmarks60, such as anatomical landmarks. Again, the landmarks or fiducialpoints are identifiable on the images and identifiable and accessible onthe patient 14. The landmarks 60 can be artificial landmarks 60 that arepositioned on the patient 14 or anatomical landmarks that can be easilyidentified in the image data. The artificial landmarks, such as thefiducial markers 60, can also form part of the dynamic reference frame54, such as those disclosed in U.S. Pat. No. 6,381,485, entitled“Registration of Human Anatomy Integrated for ElectromagneticLocalization,” issued Apr. 30, 2002, herein incorporated by reference.

The system 10 may also perform registration using anatomic surfaceinformation or path information as is known in the art (and may bereferred to as auto-registration). The system 10 may also perform 2D to3D registration by utilizing the acquired 2D images to register 3Dvolume images by use of contour algorithms, point algorithms or densitycomparison algorithms, as is known in the art. An exemplary 2D to 3Dregistration procedure is set forth in U.S. Ser. No. 10/644,680,entitled “Method and Apparatus for Performing 2D to 3D Registration”filed on Aug. 20, 2003, hereby incorporated by reference.

Also as discussed herein, a substantially fiducial-less registrationsystem can be provided, particularly if the imaging device 12 and thetracking system 44 are substantially integrated. Therefore, the trackingsystem 44 would generally know the position of the imaging device 12relative to the patient 14 and fiducials may not be required to createregistration. Nevertheless, it will be understood that any appropriatetype of registration system can be provided for the navigation system10.

In order to maintain registration accuracy, the navigation system 10continuously tracks the position of the patient 14 during registrationand navigation. This is because the patient 14, dynamic reference frame54, and transmitter coil array 46 may all move during the procedure,even when this movement is not desired. Alternatively the patient 14 maybe held immobile once the registration has occurred, such as with a headframe. Therefore, if the navigation system 10 did not track the positionof the patient 14 or area of the anatomy, any patient movement afterimage acquisition would result in inaccurate navigation within thatimage. The dynamic reference frame 54 allows the electromagnetictracking system 44 to register and track the anatomy. Because thedynamic reference frame 54 is rigidly fixed to the patient 14, anymovement of the anatomy or the coil array 46 is detected as the relativemotion between the coil array 46 and the dynamic reference frame 54.This relative motion is communicated to the coil array controller 48,via the navigation probe interface 50, which updates the registrationcorrelation to thereby maintain accurate navigation.

The navigation system 10 can be used according to any appropriate methodor system. For example, pre-acquired images, atlas or 3D models may beregistered relative to the patient and patient space, as discussedfurther herein. Generally, the navigation system allows the images onthe display 34 to be registered and accurately display the real timelocation of the various instruments and other appropriate items, such asthe trackable pointer. In addition, the pointer may be used to registerthe patient space to the pre-acquired images or the atlas or 3D models.In addition, the dynamic reference frame 54 may be used to ensure thatany planned or unplanned movement of the patient or the receiver array46 is determined and used to correct the image on the display 36.

With additional reference to FIG. 2, the dynamic reference frame 54 canbe affixed to any appropriate portion of the patient 14, and can be usedto register the patient to the image data, as discussed above. Forexample, when a procedure is being performed relative to a cranium 17,the dynamic reference frame 54 can be interconnected with the cranium17. The dynamic reference frame 54 can be interconnected with thecranium 17 in any appropriate manner, such as those discussed hereinaccording to various embodiments.

To obtain a maximum reference it can be selected to fix the dynamicreference frame 54 in each of at least 6 degrees of freedom. Thus, thedynamic reference frame 54 can be fixed relative to axial motion X,translational motion Y, rotational motion Z, yaw, pitch, and rollrelative to the portion of the patient 14 to which it is attached. Anyappropriate coordinate system can be used to describe the variousdegrees of freedom. Fixing the dynamic reference frame relative to thepatient 14 in this manner can assist in maintaining maximum accuracy ofthe navigation system 10.

In addition the dynamic reference frame 54 can be affixed to the patientin such a manner that the tracking sensor portion thereof is immovablerelative to the area of interest, such as the cranium 17. A head bandmay form a part of the dynamic reference from 54. Further, astereotactic frame, as generally known in the art, can be attached tothe head band. Such systems for tracking and performing procedures aredisclosed in U.S. patent application Ser. No. 10/651,267, filed on Aug.28, 2003, and incorporated herein by reference.

The instrument 52 can be a DBS probe, a MER device, a catheter, etc. andeach can include at least one of the tracking devices, such as thetracking device 58. The tracking device 58 can be any appropriatetracking device and can be formed in any appropriate manner such as thecatheters described in pending U.S. patent application Ser. No.11/241,837, filed on Sep. 30, 2005, incorporated herein by reference.

The catheter 52 can include the tracking device 58 at any appropriateposition, such as near a distal end of the catheter 52. By positioningthe tracking device 58 near the distal end of the catheter 52 knowing ordetermining a precise location of the distal end can be efficient.Determining a position of the distal end of the catheter 52 can be usedto achieve various results, such as determining a precise position ofthe distal end of the catheter 52, a precise movement of the distal endof the catheter 52. It will be understood that knowing a position andmoving the catheter 52 in a precise manner can be useful for variouspurposes, including those discussed further herein. Likewise, thecatheter 52 can be directable according to various mechanisms and suchas directing or pulling wires, directing or pulling signals, or anyappropriate mechanism generally known in the art.

The catheter 52 can be used for various mechanisms and methods, such asdelivering a material to a selected portion of the patient 14, such aswithin the cranium 17. The material can be any appropriate material suchas a bioactive material, a pharmacological material, a contrast agent.Instead of a material, a therapy such as electrical stimulation can beused with a deep brain stimulation probe (DBS). The DBS can be used toapply a voltage, a pulse width, etc. to a selected portion of the brain.

As mentioned briefly above, the display 34 can display any appropriatetype of image data 36. For example, the image data 36 can includepatient specific image data that can be acquired at any appropriatetime. The image data can include magnetic resonance imaging data (MRI)that can provide structural anatomical image data of the patient 14. Theimage data can be displayed on the display 34 for use during a procedureby the user 67. The display on the display 34 can also include variousatlas image data. Atlas image data can include two-dimensional imagedata sets, three-dimensional image data sets, and even four-dimensionalimage data sets that show the change of various anatomical structuresover time.

With reference to FIG. 3, a three-dimensional atlas data set 100 isillustrated for a neurological region. The neurological regionillustrated in FIG. 3 can be any appropriate neurological region, suchas a sub-thalamic nucleus, a cerebrum, or the like. In addition, thethree-dimensional atlas 100 can be used to identify various regions ofthe anatomy of the patient 14 on the display 34. For example, the atlasimage 100 can be registered to the image data 36 in any appropriatemanner. For example, the atlas can be registered to the image data usinggenerally known algorithms, registration or fiducial markers, and thelike. Nevertheless, the 3-D atlas 100 can be used to identify or assistin identifying various landmarks within the image data 36 of the patient14. Certain algorithms can include shape matching, space matching, orstructure matching. Shape fitting algorithms can include least squarefitting to match one image to another.

With reference to FIG. 4, a 2-D atlas image data 102 can be overlaid onthe image data 36 of the patient 14. The display 34 can include variousregions that show the image data 36 of the patient 14 from a pluralityor any appropriate perspectives. In addition, the display device 34 candisplay a position of the instrument 52 with an icon 52 i. The icon 52 ican illustrate a position of the instrument 52 relative to a selectedportion of the anatomy, such as identified by the atlas 102 or any otherappropriate procedure. The atlas 102 can also be registered to the imagedata 36 of the patient 14 according to various known techniques,including various automatic or manual registration techniques. Theregistration of the atlas data 102 to the image data 36 can assist inidentifying various anatomical and functional landmarks or portions ofthe anatomy of the patient 14.

With reference to FIG. 5, the display 34 can be used to display varioustypes of image data, including the image data 36 of the patient 14, andatlas image data relative thereto. The appropriate type of image datadisplayed on the display 34 can then be used to plan a selectedprocedure. The planning can occur substantially pre-operatively orintra-operatively. Nevertheless, various targets 104, 106 can bedisplayed on the display 34 as can various trajectories 108, 110. Thetargets 104, 106 and the trajectories 108, 110 can be displayed on thedisplay 34 for selection by the user 67. It will be understood that theplan can be prepared at any appropriate time to assist in performing theprocedure with the navigation system 10. Also, the plan can be createdmanually, automatically, or combinations thereof. The plan, including atarget and trajectory, can then be selected manually, automatically, orcombinations thereof.

The planning procedure can use the atlas data, and functional data,discussed further herein, to assist in determining the appropriatelocation of the targets 104, 106. In addition, the anatomical andfunctional features identified in the image data 36 can be used toassist in determining the appropriate trajectory 108, 110. Variousaiming devices can also be tracked in addition to tracking theinstrument 52, as discussed further herein. The identification ofappropriate trajectories 108, 110 or the selection of one of manytrajectories, such as the selected trajectories 108, 110 can be used toassist in positioning an appropriate aiming device or the instrument 52during a procedure.

The planning information displayed on the display 34 can also be usedpost-operatively to determine whether the device, such as a deep brainstimulation probe, was implanted or positioned at an appropriatelocation, such as a planned location 104, 106. The planning informationdisplayed on the display 34 can be compared to post-operative imagedata, such as a post-operative MRI of the patient 14, to assist indetermining the success or the final positioning of the selectedimplant. In addition, the post-operative information can be used withthe optimization/programming system for the device in block 5 to assistin ensuring that an appropriate lead, therapy, or the like is providedto the selected or target location. Therefore, the planning informationon the display 34 can be used to assist in ensuring that an appropriatetherapy is provided to the patient, as discussed further herein.

With reference to FIG. 6, various types of anatomical or physiologicalinformation can be collected using any appropriate system and can beprovided as the data 2. For example, a micro-electrode recorder (MER)can be moved through the anatomy of the patient 14. The image data 36can be displayed on the display 34 and a position of the MER, which canbe the instrument 52, can be displayed as the MER icon 120. The MER icon120 can be displayed or superimposed on the image data 36 and also onthe atlas data 102. Although the atlas data 102 can assist indetermining a position of a selected location in the image data 36, theMER can be used to assist in further refining a location within theanatomy of the patient 14. Additional icons, such as bread crumb icons122 can be displayed superimposed on the image data 36, the atlas data102, etc. to illustrate various changes or sensed anatomical locationsbased upon the information recorded by the MER. The bread crumbs 122 canassist in determining a selected region, such as a functional oranatomical region, within the image data 36. A generally known recordingfor a selected region of the anatomy can be recorded with the MER 120 toverify the identity of an anatomical or functional portion and alocation of the MER 120 can be determined via the navigation system 10.The determined location of a selected region, such as the thalamus, canbe detected with the MER and can be displayed on the display 34 with oneof the bread crumbs 122. The atlas location from the atlas data 102 canthen be refined when being superimposed on the image data 36 of thepatient 14. Also, refinement of the atlas data 102 can also be used torefine the location of other atlas or mapped locations that areillustrated with the atlas data 102.

The data used to refine the atlas data 102 or the data 2 can also beused during an operative procedure. The anatomy and neurophysiology thatis depicted by the atlas data 102 and the plan created may show theprobe as navigated in one location, but the intra-operative functionaldata may confirm it to be in another location (due to clinical shifting,etc.). To determine the next steps, or help refine a trajectory, path,or treatment should be chosen for the therapy, the atlas data 102 can bemanipulated to match the intra-operative functional and observed data

It will be understood that any appropriate recording or sensing devicecan also be used in addition or alternatively to the MER. Otherappropriate or selected sensing probes, such as an optical coherencesensor, or the like can be used to provide an appropriate anatomical orfunctional landmark or structure information. The atlas 102 can beenhanced or further augmented based upon the probe information to assistin determining an appropriate transformation or customization of theatlas relative to the image data 36. It will be further understood thatthe atlas data can be the 3D atlas data 100 or any other appropriateatlas data and need not necessarily be the 3D atlas data.

As discussed above, the atlas data, which can include the 3D data 100 or2D data 102, can be provided. The 2D and 3D data can be displayed forviewing on the display device 34. Further, the atlas data informationcan be registered with the patient image information. The registrationcan include custom patient alignment. For example, the anteriorcommissure and the posterior commissure can be determined with Talairachscaling. Also, basal ganglia and local non-linear alignment or globalnon-linear alignment can be determined. The data can be used for digitalmapping of the selected portion of the anatomy, such as the brain.Further, automatic fit or cell types can be determined. That is, celltypes in the image data can be determined and displayed on the display34 for use by the user 67. In addition, the MER can be used forautomated fitting, such as by determining or assisting the determinationof different cell types or anatomical or functional regions and fittingthe atlas 100, 102 to the image data 36. In addition, back projection ofphysiology or back projection of therapeutic contacts can be used inphysical atlases.

The atlas data allows for the statistical or general mapping orindication of various portions of the anatomy, such as portions in thebrain, portions in the spinal cord, various anatomical features, or thelike. Atlas data can be based upon various procedures or studies, suchas well understood and studied anatomical scans. For example, theSchaltenbrand-Wharen or Talairach atlases are generally accepted andwell understood atlases of the human brain. Portions that are identifiedwithin the Schaltenbrand-Wharen or Talairach atlases can be the atlasdata that is used, as discussed above, and herein.

The atlas data can be used at any appropriate time. For example, theatlas data can be superimposed or registered to the image data of thepatient for planning a procedure. The atlas data can also besuperimposed or registered to the image data for use during a procedure,such as to assist in navigation. The additional instruments, such as theMER, can be used to verify the locations of various portions of theanatomy based upon the atlas data. The MER can be introduced into thebrain to record activity within the brain to confirm locationsidentified with the atlas data.

The feedback loop 6 in the optimization procedure 1 can be used toenhance the atlas data. The atlas data can be stored in the memorysystem, or any appropriate memory system, and can be augmented basedupon information from the procedure or post procedure follow-up. Thedetected or confirmed location of an anatomical feature or target, canbe used to augment or provide a statistical range of the atlas data foruse in future procedures. It will be understood, the atlas data canrepresent any appropriate data 2.

The atlas data can also be used post operatively. For example the atlasdata can be superimposed onto image data acquired post operatively of apatient. The atlas data can be used to confirm long time positioning ofvarious implants or instruments, such as DBS leads. Therefore, the atlasdata can be used at any appropriate time relative to a procedure time.

With reference to FIG. 7, the image data 36 can be displayed on thedisplay 34. The instrument 52 can include a deep brain stimulation probe140. The DBS probe 140 can be the instrument 52 being tracked fordetermining its position in the brain. In addition, the stereotacticframe 80 can be provided according to various embodiments as an aimingdevice 142. According to various embodiments, including those discussedabove, a tracking device can be positioned relative to the DBS probe.For example, a tracking device can include a small electromagnetic coilpositioned at a tip 144 of the DBS probe 140. In addition, thestereotactic or aiming device 142 can be tracked by the tracking system44 for navigation with the navigation system 10. Regardless, thelocation of the tip 144 of the DBS probe 140 can be displayed relativeto the image data 36. For example, an icon can be displayed on orrelative to the image data 36 for illustration of the position of thetip 144 of the DBS probe while performing the procedure in block 4.

The provision of the various atlas data 100, 102 and the image data 36of the patient 14, including other information, such as thephysiological data from block 2 c, can assist in registration anddetermination of various targets and an appropriate aiming of the aimingdevice 142. In addition, the tip 144 of the DBS probe 140 can besubstantially precisely tracked due to various elements, such as thepositioning of the tracking device 58 at the tip 144, the aiming device142, or other appropriate mechanisms. Regardless, the exact location ofthe tip 144 can be navigated relative to a selected portion of thepatient 14, such as the target 104, 106 defined during the planningprocedure. This can allow for determination or correct placement of aselect instrument, such as a DBS probe. It will be understood that anyappropriate instrument can be positioned relative to the patient 14 andthe DBS probe is merely exemplary. However, the precise positioning, inaddition to determination of the appropriate target based on the dataprovided as discussed above, can assist in performing the appropriateprocedure.

Although the procedure can be navigated, as illustrated in FIG. 7,direct visualization can occur via the imaging system 12 or anyappropriate imaging system. Returning reference to FIGS. 2, 2A and 2B,the navigation system 10′ can include an alternative imaging device 12′,such as an intraoperative MRI system 12′ (FIG. 2A) or O-Arm™ imagingsystem 12″ (FIG. 2B). A work station 31′ can be provided to controlvarious portions, such as the alternative imaging device 12′, and theoptical localization system 44″. Therefore, one skilled in the art willunderstand that the appropriate navigation system can be provided andthe navigation systems 10, 10′ are merely exemplary. Further, directvisualization can be used to assist in the performing of the selectedprocedure. Therefore, navigation, with or without images, is merelyexemplary and can be used to assist the user 67 in performing a selectedprocedure.

As illustrated in FIG. 7, the instrument 52 can include a the DBS 140.When positioning the DBS probe 140, it can be navigated with anelectromagnetic navigation system or electromagnetic tracking system, asdiscussed above. In addition, the DBS probe 140 or any appropriateinstrument can be positioned with no line of sight navigation. This caninclude positioning or navigation of the instrument simply by navigatingthe instrument based upon the various visualization techniques,including the image data obtained of the patient and registered tovarious atlas information or other appropriate systems.

Further, the image data can be used for navigation by the user 67 withthe navigation system 10, 10′ in any appropriate manner. As discussedabove, fiducials 60 can be provided for use to register patient space toimage space. Alternatively, or in addition thereto, substantiallyfiducial less registration can be provided. Fiducialless registrationcan include providing an imaging system 12, 12′, 12″ integrated with thetracking system 44, 44′, 44″. The imaging system 12, 12′, 12″ can beintegrated into the tracking system 44, 44′, 44″ so that the position ofthe imaging device 12, 12′, 12″ is known by the tracking system 44, 44′,44″ so that the navigation system 10, 10′ acts as one system. In thiscase, fiducials may not be required to register the image data with thepatient space.

In addition, substantially automatic registration can includepositioning the tracking device 54 a substantially on the top orintegrally with the fiducial 60 During the acquisition of the images,the fiducial 60 is present and the tracking device 54 a can beinterconnected with the fiducial 60 or at substantially the samelocation after imaging. Therefore, the tracking system 44 can determinethe position of the tracking device 54 a once the patient 14 is movedinto the localization field and substantially automatic registration canoccur if the fiducial points in the image data are determined.

With integration of the imaging system and the tracking system, theintegrated navigation system can be provided for post-operativeconfirmation. That is the navigation system can be used to confirm thepositioning of the instrument, such as the DBS probe 140, in theprocedure. The post-operative confirmation can be substantiallyimmediately post-operative or at a later time, but can be used to ensurethe appropriate positioning of the probe 140. The position of the probe140 can again be determined based upon the atlas information, which canbe provided relative to post-operative image data or any otherappropriate system.

As discussed above, any appropriate procedure can occur. For example,the positioning of a deep brain stimulation probe 140 can be performed.As is generally known in the art, the deep brain stimulation probe isthen programmed or can be programmed post-operatively to apply aselected therapy, such as a voltage to the area of the anatomy relativeto positioning of the probe. It will be understood, however, that anyother appropriate therapy can be provided, such as a pharmaceuticaldelivery, a gene or cell therapy, a radiation therapy, or the like. Theexemplary discussion of a deep brain stimulation programming is providedfor illustration. Further, as discussed above, the appropriatepositioning of the deep brain stimulation probe can be provided basedupon atlas data, physiological, or patient specific data (e.g., imagedata of the patient, physiological data of the patient, MER data of thepatient, optical coherence tomography data of the patient).

With reference to FIG. 8, the various physiological data can be providedwith any appropriate system, such as the MER, optical coherencetomography, or the like. Further, these various instruments can betracked with the tracking system 44, 44′, 44″ as discussed above.Therefore, the exact position of various portions of the anatomy, suchas portions of the brain, can be determined and sensed with the varioussensing probes or recorders. This can allow the image data to besubstantially real time mapped for use in the procedure in block 4. Forexample, the atlas data 102, 104 can be substantially real time updated,morphed or translated for use during the procedure with sensing probes,such as the MER. This can assist in determining an exact location ofvarious anatomical structures or functional structures for assisting indetermining a selected position to implant the DBS probe 140, or anyappropriate system or implant. The determination of physiological datacan assist during a procedure to ensure an appropriate identification ofa selected anatomical or functional structure and can assist inupdating, in substantially real time, a selected physical or functionalmap of the anatomy. Tracking the instrument while determining thephysiological feature assists in its appropriate determination andlocation.

The placement and appropriate therapy can be determined using thevarious data, such as the patient specific data, including physiologicalimage data, and atlas data. For example, the work station 31,illustrated according to various embodiments in FIG. 8, can include thedisplay 34 that displays the image data 36 and the atlas data 102.Further, displayed relative to the image data 36 and the atlas data 102can be an icon 150 illustrating a position of the DBS probe 140 in theanatomy. The illustration of the probe as the icon 150 can also beprovided for substantially post-operative programming of the implant.

It will be understood that the position of the probe in the anatomy canbe determined in any appropriate manner, such as based upon thenavigation during the procedure, based on post-operative imaging of thepatient, based on post-operative tracking of the tracking sensor, or anyappropriate manner. Nevertheless, the determination of the position ofthe probe and its illustration as the icon 150 relative to the imagedata 136 can be used to assist in programming the DBS probe or lead inan appropriate manner. Further, the various data collected during theprocedure can also be illustrated relative to the image data 36 and theatlas data 102, such as the neuro-physiological data that can becollected with the various instruments, such as the MER or opticalcoherence tomography. This information, including the physiologicaldata, functional data, and location data, can also be used for laterprogramming and operation of the DBS lead. For example, the location ofthe lead relative to a functionally identified region of the anatomy canbe used to assist in programming the amount of therapy to be deliveredfrom the lead.

With continuing reference to FIG. 8, the workstation 31 can be used toprogram an implant, such as the DBS probe or lead. It will be understoodthat the workstation 31 can be the workstation 31 used during thenavigation or can be any appropriate workstation. The workstation 31 canallow programming of the DBS probe in a generally known manner.Information from the procedure during which the implantation of theinstrument occurred can be used. Further, the data from block 2 of theoptimization procedure can be used to assist in the programming of theimplants. Programming the implants can include determining a voltagelevel, determining a pulse width, frequency, power level, frequency, orother features. The information from the procedure, such as the exactlocation within the brain, the determined anatomical or functionalstructures near the position of the implant, or the like can be used inprogramming the implants. Therefore, the information obtained during aprocedure can be used both in a general statistical sense, for use withother patients, and for use in post-operative work on a specificpatient.

With reference to FIGS. 9A and 9B, the display of the image data 36including the icon 150 of the DBS probe can be illustrated relative to afirst therapy icon 152 a. It will be understood that the representationof the atlas 102 can also be included if selected, and its absence fromFIGS. 9A and 9B is merely for clarity of the illustration. Nevertheless,when the probe is being programmed, which can occur substantiallyintraoperatively or post-operatively, a selection of a voltage, a pulsewidth, or other appropriate programmable features, including a selectionof appropriate leads can be used.

The therapy icon 152 a can illustrate an assumed or predicted treatmentaffected area. The therapy icon 152 a can illustrate a size, densityamount, etc. of the therapy. The therapy icons, according to variousembodiments, generally illustrate a localized affect on the anatomy. Thelocalized affect or treatment area can be based upon the data 2.Generalized affects on the patient can be determined after the therapyis applied, such as reduction of Parkinson's disease symptoms.

The first or initial therapy icon 152 a can illustrate an affected areabased upon a selected or programmed therapy for viewing by a user, whichcan include the surgeon 67. It will be understood that the initialtherapy icon 152 a can illustrate a size, a geometry, a density, and thelike of the therapy that is selected or programmed. It will beunderstood that the initial icon 152 a can merely be a virtualrepresentation of the predicted effect of a selected therapy. Inaddition, it will be understood that the image data 36 and the variousicons can be two-dimensional, three-dimensional, four-dimensional or thelike. Therefore, the representation of the two-dimensional image data 36and the two-dimensional initial therapy icon 152 a is merely exemplary.Nevertheless, the initial therapy icon 152 a can illustrate the possibleor selected affect area of a selected therapy on the anatomy.

Turning to FIG. 9B, the image data 36 can be illustrated with the probeicon 150 and a secondary therapy icon 152 b. The secondary therapy icon152 b can illustrate a predicted affect of a second selected therapy,such as a higher pulse width. The higher pulse width may affect a higherdensity or higher number of cells within a selected geometrical region.Therefore, the second therapy icon 152 b can illustrate or graphicallyillustrate the higher density of the cells being affected. Therefore,the initial therapy icon 152 a can be substantially transparent whilethe second therapy icon 152 b may be substantially opaque.

The icons 152 a, 152 b can illustrate representation of a possible orselected therapy on the patient prior to instigating a therapy on thepatient. This can allow for substantially a graphical programming of theimplant to make the programming of the implant more efficient andrequire fewer attempts to obtain an optimal therapy. The predictedaffect using the therapy icons 152 a, 152 b can also be used during theprocedure to ensure that an instrument is positioned in an appropriatelocation for the selected or predicted therapy.

The therapy icons 152 a, 152 b, according to various embodiments, can beused to predict an area that will be affected by therapy, ensure that aninstrument is implanted in the appropriate location for providing atherapy, or a procedure to position an instrument to provide a therapy.Therefore, it will be understood, that the therapy icons are not onlyprovided for a single part of the procedure, but can be provided formultiple parts of the procedure. The therapy icons can be used to plan aprocedure, perform a procedure, and post operatively to provide atreatment to the patient. In any of these situations, the icons can bedisplayed on the display device for use by the user 67 to optimize thetherapy for the patient 14.

In addition to a therapy density, a therapy field of shape, depth, orother geometry can also be selected and visualized. With reference toFIGS. 10A and 10B, and initially to 10A, the image data 36 can beillustrated relative to a second initial therapy icon 160. The secondinitial therapy icon can include two lobes or portions 160 a and 160 b.The two portions 160 a, 160 b of the second initial therapy icon 160 aremerely exemplary of any appropriate or possible geometrical shape.Nevertheless, the second initial therapy icon 160 can illustrate that aproposed or selected therapy will affect a region generally having alongitudinal axis A. The longitudinal axis A may be provided relative tothe image data 36 for viewing by the user 67. The longitudinal axis Aand the icon portions 160 a, 160 b can be used by the user to determinewhether a selected geometrical area is appropriate for the providedtherapy. Further, the icon portions 160 a, 160 b can also includediffering opacities to represent different densities of the therapy.

With reference to FIG. 10B, a secondary therapy icon 170 is illustrated.The second secondary therapy icon 170 can include a first portion 170 aand a second portion 170 b. The two portions 170 a and 170 b can definea longitudinal axis B relative to the image data 36. The longitudinalaxis B can be different than the longitudinal axis A, such as includinga different angle relative to the image data 36. Although the iconportions 170 a, 170 b can include different opacities or similaropacities, the icons can represent a different geometrical shaperelative to the image data 36 of the patient 14. The differentgeometrical shapes can illustrate a different geometrical application ofthe therapy relative to the patient, illustrated in the image data 36.

The therapy icons can be illustrated in any appropriate orientationrelative to the image data or atlas data. The illustration of thetherapy icons, whether to illustrate a different size, different therapytype, different therapy amounts, or the like can be illustrated forprocedure planning, procedure performance, or post operative treatmentprovisions. Moreover, the therapy icons can be illustrated to assist auser in determining an appropriate or optimal therapy provision. Forexample, the user can view on the display device the predicted therapyand determine the effect of the treatment on the patient. Therefore, thetherapy icons can be used to determine whether a predicted therapy ishaving a predicted affect on the patient 14.

It will be understood that the various icons 152, 160 and 170 canrepresent two-dimensional, three-dimensional, four-dimensional, or anyappropriate geometrical shapes. The icons provide a graphicalrepresentation of a proposed or selected therapy on the image data 36 ofthe patient 14. The icons 152, 160, 170 can illustrate a depth,geometry, affected area, amount of affected cells, charge over time,etc. of the selected therapy. The graphical representation can be usedby the user 67 to assist in determining the appropriateness of theselected therapy. In addition, the graphical representation can be usedto ensure that the therapy is being provided to an appropriate locationwithin the anatomy. Again, the provision of the atlases 102, 104 canassist in this. Also, the various data that is determinedintraoperatively or post-operatively, such as the physiological data,can be used to ensure or augment or customize the atlases relative tothe particular patient 14. Therefore, the image data 36 during theprogramming phase in block 5 can also be illustrated or displayedrelative to the atlas data to assist in determining whether the therapyis being applied to a selected or appropriate location.

Thus, one skilled in the art will understand that the optimizationsystem 1 can be used to assist in all of a preoperative planning, anintraoperative procedure, and a post-operative follow up or programming.The programming can be of any appropriate system, such as the deep brainstimulator, a therapy application, a pacer, or any appropriate implantsystem. In addition, the optimization system 1 can include anyappropriate or be used with any appropriate navigational or imagingsystem to assist in obtaining the appropriate image data. Also thevarious probes or sensors, such as the MER, can be used to assist incustomizing an atlas relative to the particular patient to assist inlocating or determining appropriate anatomical or functional regions.

The optimization system 1, diagrammatically illustrated in FIG. 1, andtaught and described above, can be provided with a substantiallygraphical user interface (GUI) to assist in performing a procedure. Asillustrated in FIG. 11, a system with a selected GUI can be provided foruse with the system 1. The various illustrations include exemplaryscreen shots from the work station 31. The image data 36 can be providedon the display 34 for manipulation by a user employing the user input38. As illustrated above, various types of data can be provided thatinclude those graphically illustrated in block 202 in FIG. 11. It willbe understood that additional information can also be provided,including an optical coherence data, illustrated in FIG. 12 below. Theoptical coherence data 220 can be displayed relative to a graphical ordiagrammatic representation of the brain 221 and an instrument obtainingthe optical coherence data.

The data, with reference to FIGS. 11 and 12, can include image data 36and an initial atlas fitting, such as the two-dimensional atlas 102. Inaddition, various types of physiological data can be provided, such aswith an MER that can create or report an electrical signal 204. Theelectrical signal 204 can be illustrated on the display 34 and can alsobe illustrated relative to a diagram or position of the MER, in theanatomy of the patient 14 relative to the image data 36. A substantiallypre-registered or custom display of the atlas data can be provided orillustrated at block 206. The various data, such as data recorded by theMER can be illustrated as various icons 208. The various icons 208 orthe data recorded by the MER can be used to create a substantiallycustom or real time registration or morph of the atlas data 102 to theimage data 36 of the patient. This can allow substantially real-timeregistration of the atlas 102 to the patient data 36. This can alsoallow for a substantially precise locating or positioning of variousportions, such as a deep brain stimulation probe relative to the patientusing the image data 36.

A graphical planning can be provided based upon the various datacollected either intraoperatively or preoperatively. The planning,graphically illustrated at 210, can occur at any appropriate time, asdiscussed above. Further, the planning or planned procedure can bechanged substantially intraoperatively based upon obtained information,including the substantially real time registration or morphing of theatlas data 102 to the patient data or image data 36.

The various types of data can then be used to assist in programming orselecting a particular therapy. The optimization programming of block 5is graphically illustrated in block 212. As discussed above, the variousgraphical displays can illustrate icons that illustrate how a therapy ispredicted to affect various portions of the anatomy and can be used tosubstantially, precisely and efficiently program a particular therapy,such as a deep brain stimulation, cell therapy, gene therapy, or thelike. Nevertheless, the icons can assist in determining or illustratinghow a therapy will likely affect various portions of the anatomy and canbe used to assist in more precisely or efficiently programming thesystem. Also as discussed above, the illustration of how a therapy mightaffect the anatomy can be used in planning the procedure, such asselecting an appropriate target, trajectory, or the like.

Moreover, the target can be reached based upon a linear or non-linearpath. Optimization of a therapy can include determining the appropriatepath and trajectory to reach a selected location in the anatomy. Again,the data 2 can assist in identifying regions of the anatomy to provide atreatment to and assist in identifying the trajectory or path to reachthe target for therapy.

One skilled in the art will understand that the predicted affected ortherapy icons illustrated an empirical physiological effect. The actualeffect on the patient's symptoms can differ from patient to patient.Therefore, the icons can be used in future models and also to determinean amount or location of treatment provided to a selected patient. Asthe therapy for the selected patient is refined, reference can be madeto the previous therapy areas or type illustrated with the icons.

The description of the present teachings is merely exemplary in natureand, thus, variations that do not depart from the gist of the presentteachings are intended to be within the scope of the present teachings.Such variations are not to be regarded as a departure from the spiritand scope of the present teachings.

What is claimed is:
 1. A system for performing a procedure on an anatomyof a patient, comprising: a first memory system configured to storedatabase data; an instrument having a sensor configured to be positionedin a brain of the patient to obtain functional patient specific data;and a processor operable to access the first memory system and operableto execute instructions to: perform an initial registration of a patientspecific image data and the database data, and perform a secondregistration of the patient specific image data and the database dataafter the initial registration based at least in part on the functionalpatient specific data obtained with the sensor from the patient with theinstrument having the sensor.
 2. The system of claim 1, wherein thedatabase data includes atlas data, average functional data, thefunctional patient specific data previously acquired, or combinationsthereof.
 3. The system of claim 1, further comprising: a display deviceoperable to display the patient specific image data after performing thesecond registration; and wherein a first icon is displayed on thedisplay device to identify a target in the patient specific image datadisplayed on the display device.
 4. The system of claim 3, wherein thefirst icon is illustrated at a location defined via a user input, anautomatic determination of the target by the processor, or combinationsthereof.
 5. The system of claim 3, wherein a second icon is displayed onthe display device operable to illustrate a predicted localizedphysiological affect of a therapy superimposed on the patient specificimage data.
 6. The system of claim 5, wherein the second icon displays alocalized physiological affect of a voltage, an affect of a pulse width,an affect of a chemical volume delivered, an affect of a biologicaltreatment delivered, an affect of a radiation treatment delivered, anaffect of therapy over time, or combinations thereof.
 7. The system ofclaim 6, further comprising: a deep brain stimulation lead operable tobe implanted in the anatomy of the patient; and a treatment deviceoperable to be programmed to provide a therapy through the deep brainstimulation lead implanted in the anatomy based at least in part on thelocalized physiological affect displayed on the display device.
 8. Thesystem of claim 7, further comprising: a tracking system including alocalizer and a tracking device, wherein the tracking device isassociated with at least one of the deep brain stimulation lead or theinstrument.
 9. The system of claim 1, further comprising: an imagingsystem operable to obtain the patient specific image data; and atracking system including a localizer and a tracking device; wherein aposition of the tracking device is operable to be determined andindicated relative to the patient specific image data.
 10. The system ofclaim 1, wherein the functional patient specific data includes at leastone of a microelectrode recording data, a pressure data, a gating data,or combinations thereof.
 11. The system of claim 1, wherein theinstrument includes at least one of a microelectrode recorder, acatheter, a scope, a pressure monitor, or combinations thereof.
 12. Asystem for performing a procedure on an anatomy of a patient,comprising: an electronic processor to execute instructions to performan initial registration of a patient specific image data and a databasedata at a first time; and an instrument having a sensing portionconfigured to be placed within the anatomy of the patient and to obtainfunctional patient specific data after the first time with the sensingportion; wherein the electronic processor executes further instructionsto perform a second registration of the patient specific image data andthe database data at a second time after the first time based at leastin part on the functional patient specific data obtained with theinstrument.
 13. The system of claim 12, further comprising: a firstmemory system configured to store the database data; wherein theelectronic processor is in communication with the first memory system.14. The system of claim 13, further comprising: a display device incommunication with the electronic processor and configured to displaythe patient specific image data after at least the second registration.15. The system of claim 14, further comprising: a tracking system havingat least a tracking device associated with the instrument operable witha localizer to track a location of the instrument.
 16. The system ofclaim 15, wherein the tracking system includes at least one of anelectromagnetic localizer or an optical localizer.
 17. The system ofclaim 15, wherein the electronic processor is configured to executeinstructions to illustrate a tracked location of the instrumentsuperimposed on the patient specific image data illustrated with thedisplay device.
 18. The system of claim 13, further comprising: animaging system operable to obtain the patient specific image data forregistration to the database data.
 19. A system for performing aprocedure on an anatomy of a patient, comprising: an instrument having asensing portion to sense functional patient specific data in at leastone location within the anatomy of the patient; a tracking system havingat least a tracking device associated with the instrument to track theinstrument in the at least one location within the anatomy of thepatient; an electronic processor to execute instructions to perform arefined registration of a patient specific image data and a databasedata based upon at least one tracked location of the instrument; and adisplay device configured to display the patient specific image data andat least one icon superimposed on the patient specific image datadisplayed on the display device illustrating the at least one locationof the functional patient specific data sensed with the sensing portion;wherein the refined registration follows an initial registration. 20.The system of claim 19, wherein the electronic processor is furtherconfigured to execute instructions to perform the initial registrationof the patient specific image data and the database data prior to therefined registration.
 21. The system of claim 20, further comprising: adeep brain stimulation lead configured to be placed at a patient targetlocation represented in the patient specific image data.
 22. The systemof claim 21, further comprising: an imaging system configured to obtainthe patient specific image data.
 23. The system of claim 19, wherein theelectronic processor is further configured to execute instructions todetermine a patient target based on the performed refined registration.